FDA Oversight of Medical Devices: Efforts & Developments

The FDA is responsible for overseeing the safety and effectiveness of medical devices sold in the United States. New devices are generally subject to FDA review via the 510(k) process, which determines if a device is substantially equivalent to another legally marketed device, or the more stringent pre-market approval process, which requires evidence providing reasonable assurance that the device is safe and effective. This book examines whether the FDA is sufficiently meeting the performance goals and whether devices are reaching the market in a timely manner.

Preface; Medical Devices: FDA Has Met Most Performance Goals but Device Reviews are Taking Longer; Pediatric Medical Devices: Provisions Support Development, but Better Data Needed for Required Reporting; Medical Devices: FDA's Premarket Review & Postmarket Safey Efforts. Testimony of Marcia Crosse, Government Accountability Office delivered at the Hearing on "A Delicate Balance: FDA & the Reform of the Medical Device Approval Process"; Statement of William Maisel, Deputy Director for Science, Center for Devices & Radiological Health, Food & Drug Administration. Hearing on "A Delicate Balance: FDA & the Reform of the Medical Device Approval Process"; Testimony of David Nexon, Senior Executive Vice President, Advanced Medical Technology Association. Hearing on "A Delicate Balance: FDA & the Reform of the Medical Device Approval Process"; Index.